Revision For Adverse Reaction To Metal Debris Research Articles

Safe Upper Limits of Serum Cobalt and Chromium Levels for a Metal-on-Metal Total Hip Bearing: A 10-Year Follow-Up Study

BackgroundLong-term survival of metal-on-metal (MoM) prostheses and the development of adverse reaction to metal debris (ARMD) around these bearings are still unclear. Serum levels of cobalt (Co) and chromium (Cr) are used as a screening tool to anticipate failure in MoM bearings and detect ARMD. MethodsOne hundred sixty primary large head MoM prostheses were followed up for 10 years. To estimate the revision risk, the cumulative incidence function (CIF) was used. Subdistribution hazard modeling was used to investigate the associations between cumulative incidence of revision for ARMD and Co levels, Cr levels, gender, age, head size, and cup inclination. Furthermore, the safe upper limits (SULs) for Co and Cr were determined. ResultsUnivariate analyses showed an increased risk in revision for ARMD in females (subdistribution hazard ratio [sdHR] 3.43, 95% confidence interval [CI] 1.01-11.7, P = .049) and cup inclination angles over 45° (sdHR 4.70, 95% CI 1.63-13.58, P = .004). In addition, a higher last measured Co level (sdHR 1.05, 95% CI 1.03-1.07, P < .001) and last measured Cr level (sdHR 1.21, 95% CI 1.14-1.29, P < .001) were associated with a higher probability of revision for ARMD. We determined our bearing-specific SULs at 4.1 parts per billion (ppb) and 4.2 ppb for Co and Cr, respectively. ConclusionGuidelines regarding follow-up and surveillance should include a complete clinical assessment with bearing-specific SULs of serum metal ion levels. For the M2a-Magnum MoM bearing we advise an SUL for Co and Cr levels of 4.1 and 4.2 ppb, respectively.

Has the threshold for revision surgery for adverse reactions to metal debris changed in metal-on-metal hip arthroplasty patients? A cohort study of 239 patients using an adapted risk-stratification algorithm

Background and purpose — A risk-stratification algorithm for metal-on-metal hip arthroplasty (MoMHA) patients was devised by US experts to help clinicians make management decisions. However, the proposed algorithm did not cover all potential patient or surgical abnormalities. Therefore we adapted the US risk-stratification algorithm in MoMHA patients revised for adverse reactions to metal debris (ARMD) to determine the variability in the revision threshold, and also whether high-risk patients had inferior outcomes following revision.Patients and methods — We analysed 239 MoMHA revisions for ARMD between 2001 and 2016 from 2 centres with pre-revision blood metal ions and imaging. Patients were stratified (low risk, moderate risk, high risk) using pre-revision factors (implant, radiographic, blood metal ions, cross-sectional imaging) by adapting a published algorithm. The risk categories for each factor were assessed against revision year, revision centre, and post-revision outcomes (re-revision surgery, and any poor outcome).Results — Compared with hips revised before 2012, hips revised from 2012 onwards included more high-risk implants (44% vs. 17% pre-2012), high-risk radiographic features (85% vs. 69% pre-2012), and low-risk metal ions (41% vs. 19% pre-2012). 1 centre more frequently revised patients with high-risk implants (48% vs. 14%) and low-risk blood metal ions (45% vs. 15%) compared with the other. All these comparisons were statistically significant (p < 0.05). With the limited sample size available, implant, radiographic, blood metal ion, and cross-sectional imaging risk groups did not statistically significantly affect the rates of re-revision surgery or frequency of poor outcomes post-revision.Interpretation — When applying the adapted risk-stratification algorithm the threshold for ARMD revision changed over time, presumably due to increasing evidence, patient surveillance, and investigation since 2012. Lower blood metal ion thresholds were used from 2012 for ARMD revisions; however, there was evidence that centres attached different importance to metal ions when managing patients. High-risk patients did not have inferior outcomes following ARMD revision.

Modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty.

In total hip arthroplasty (THA), local adverse reaction to metal debris (ARMD) may be caused by abnormal metal ion release from a metal-on-metal (MoM) bearing, or by wear and corrosion of the implant's modular junction. The aim of this study was to compare ion levels and rate of ARMD between patients sharing the same MoM bearing but 1 group having monoblock stems versus another having modular stems. Whole blood cobalt (Co) and chromium (Cr) ion concentrations, ARMD rate, revision rate, and function measured by UCLA and WOMAC scores were compared between groups. ARMD rate was significantly higher in the modular group (46%) compared with the monoblock group (16%, p = 0.031). Revision for ARMD was performed at 52.8 ± 8.1 months in the modular group versus 98.2 ± 15.5 months after primary THA in the monoblock group. ARMD originated from wear and corrosion of the junction between stem and femoral head adapter sleeve in all monoblock cases, and the junction between stem and modular neck in all the modular ones. Cr and Co ions levels were significantly higher in the modular stem group ( p < 0.001 for both). Although both groups had MoM bearings, corrosion at stem/neck or neck/head junctions combining dissimilar metal (Ti and Cr-Co) was seen as the source of excess metal ions release leading to ARMD. Poor performance of the modular junction may be more deleterious than wear of the bearing. To avoid such complications, THA femoral stem modular junctions should be eliminated (return to a full monoblock implant) or have improved junction design.

How Common Is Revision for Adverse Reaction to Metal Debris After Total Hip Replacement with a Metal-on-Polyethylene Bearing Surface?: Commentary on an article by Anders Persson, MD, et al.: "Revision for Symptomatic Pseudotumor Following Primary Total Hip Arthroplasty with a Standard Femoral Stem".

Commentary Adverse reaction to metal debris (ARMD) has resulted in a high short-term rate of failure of metal-on-metal (MoM) total hip arthroplasties (THAs)1. ARMD has also been observed after non-MoM THAs. Matharu et al. reported on a retrospective observational study of data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. All 3,340 patients who underwent revision because of ARMD were included. The authors found that 95% of patients who underwent revision due to ARMD had an MoM THA, whereas 7.5% (249 patients) underwent revision of a THA with non-MoM bearing surfaces. The risk of revision due to ARMD was compared among different commonly implanted femoral head sizes and bearing surfaces. The relative risk of revision due to ARMD was 2.80 times (95% confidence interval [CI] = 1.74 to 4.36 times) higher for 36-mm metal-on-polyethylene (MoP) bearings compared with 28-mm and 32-mm MoP bearings (0.058% versus 0.021%; p < 0.001) and 2.35 times (95% CI = 1.76 to 3.11 times) higher for ceramic-on-ceramic bearings compared with hard-on-soft bearings (0.055% versus 0.024%; p < 0.001)1. Persson et al. evaluated 2,102 patients who underwent a total of 2,446 THAs, predominantly for osteoarthritis, from 1999 to 2016 in one center. In this observational cohort study, all patients underwent THA with the same uncemented Bi-Metric femoral stem and MoP (or, in a small number of cases, ceramic-on-polyethylene) articulation. The Bi-Metric femoral stem is a collarless, 3° tapered stem consisting of titanium alloy with its proximal 30% porous-coated (pore size, 100 to 200 μm) and plasma-sprayed with hydroxyapatite. The Morse-type taper consists of titanium alloy (Ti-6Al-4V) with a 4° taper angle, a distal diameter of 12.4 mm, and a contact length of 12.4 mm. The femoral heads were predominantly cobalt-chromium and 28 or 32 mm in diameter. The authors point out that the survival rate of these stems has been reported to be excellent in the literature2. The prevalence of revision for symptomatic ARMD was 0.5% (13 cases) after a mean follow-up of 7 years. The incidence rate was 0.9 case per 1,000 person-years. The strengths of this study include the evaluation of a large cohort of patients in which one well-performing cementless femoral stem was utilized. The data collection was carried out using the Swedish personal identity number and linked to the Swedish Hip Arthroplasty Register. This minimized the risk of the investigators missing additional revisions for ARMD that were carried out in other centers. It provides the incidence of revision for ARMD in one center, in a homogeneous population treated with a well-performing cementless stem with a 28-mm or 32-mm MoP articulation. The authors demonstrated that the rate of revision for symptomatic ARMD is low (0.5%) under these circumstances. They are to be congratulated for their contribution to the literature. The limitation of this study is the extent to which the data can be generalized to all THAs. The incidence of ARMD due to corrosion at the head-neck junction is multifactorial and includes implant factors, surgical factors, and patient factors. Implant factors that influence ARMD include head size, taper geometry, taper tolerances, taper surface finish, flexural rigidity of the neck, and material composition3. The findings in this study should not be applied to cohorts with different femoral head sizes or different tapers. Surgical factors that may impact the occurrence of ARMD include the surgical approach and its effect on the ability to maintain a dry, clean environment for the taper during impaction. In vitro studies have shown the cleanliness of the interface and the assembly forces to be correlated with the performance of the head-neck junction4. The findings presented by Persson et al. may not apply to centers using different surgical approaches or techniques for assembling the head-neck junction, particularly minimally invasive or anterior approaches. Finally, it is accepted that there is a large variation in an individual’s response to wear and corrosion debris generated from THAs. There is little correlation between the amount of wear and corrosion debris and the response to the debris in an individual patient. An individual patient may have substantial debris and exhibit little reaction to it while another may have a modest amount of debris but exhibit a substantial biologic response to it. This variation may be due to genetic polymorphisms, which can vary among different patient cohorts5. In conclusion, this study demonstrated a 0.5% prevalence of revision for ARMD at a mean of 7 years after MoP THAs performed in one center using 28-mm and 32-mm metal heads, a cementless femoral stem with a good long-term survival rate, and a single Morse taper. This finding should not be generalized to other patient cohorts using different femoral stems, femoral head sizes, or tapers implanted using different surgical techniques in different patient populations.

Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications.

Fretting and corrosion at the modular head/neck junction, known as trunnionosis, in total hip arthroplasty (THA) is a cause of adverse reaction to metal debris (ARMD). We describe the outcome of revision of metal-on-polyethylene (MoP) THA for ARMD due to trunnionosis with emphasis on the risk of major complications. A total of 36 patients with a MoP THA who underwent revision for ARMD due to trunnionosis were identified. Three were excluded as their revision had been to another metal head. The remaining 33 were revised to a ceramic head with a titanium sleeve. We describe the presentation, revision findings, and risk of complications in these patients. The patients presented with pain, swelling, stiffness, or instability and an inflammatory mass was confirmed radiologically. Macroscopic material deposition on the trunnion was seen in all patients, associated with ARMD. Following revision, six (18.2%) dislocated, requiring further revision in four. Three (9.1%) developed a deep infection and six (18.2%) had significant persistent pain without an obvious cause. One developed a femoral artery thrombosis after excision of an iliofemoral pseudotumor, requiring a thrombectomy. The risk of serious complications following revision MoP THA for ARMD associated with trunnionosis is high. In the presence of extensive tissue damage, a constrained liner or dual mobility construct is recommended in these patients. Cite this article: Bone Joint J 2018;100-B:720-4.

Revision surgery of metal-on-metal hip arthroplasties for adverse reactions to metal debris

Background and purpose — The initial outcomes following metal-on-metal hip arthroplasty (MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD) were poor. Furthermore, robust thresholds for performing ARMD revision are lacking. This article is the second of 2. The first article considered the various investigative modalities used during MoMHA patient surveillance (Matharu et al. 2018a). The present article aims to provide a clinical update regarding ARMD revision surgery in MoMHA patients (hip resurfacing and large-diameter MoM total hip arthroplasty), with specific focus on the threshold for performing ARMD revision, the surgical strategy, and the outcomes following revision.Results and interpretation — The outcomes following ARMD revision surgery appear to have improved with time for several reasons, among them the introduction of regular patient surveillance and lowering of the threshold for performing revision. Furthermore, registry data suggest that outcomes following ARMD revision are influenced by modifiable factors (type of revision procedure and bearing surface implanted), meaning surgeons could potentially reduce failure rates. However, additional large multi-center studies are needed to develop robust thresholds for performing ARMD revision surgery, which will guide surgeons’ treatment of MoMHA patients. The long-term systemic effects of metal ion exposure in patients with these implants must also be investigated, which will help establish whether there are any systemic reasons to recommend revision of MoMHAs

What Is the Long-term Survival for Primary THA With Small-head Metal-on-metal Bearings?

Large-head metal-on-metal (MoM) bearing hip replacements have been shown to have a much higher rate of revision than other bearing surfaces. However, small-head (≤ 32 mm) MoM bearing surfaces have been in use for many years with several reports of satisfactory mid- to long-term survivorship. It is unclear whether the long-term survival of small-head MoM devices will continue to be satisfactory or whether the same concerns seen with the large-head MoM devices will ultimately become more prevalent. We analyzed a large national registry to ask: (1) What is the 15-year Kaplan-Meier survivorship of primary conventional THA using small-head (≤ 32 mm) MoM bearing surfaces compared with large-head MoM bearing surfaces in primary THA? (2) Is there an increased rate of revision for adverse reaction to metal debris (ARMD) in this group of patients over time? The Australian Orthopaedic Association National Joint Replacement Registry longitudinally maintains data on all primary and revision joint arthroplasties with nearly 100% capture. We analyzed all conventional primary THAs performed from Registry inception in September 1999 until December 31, 2015, in patients with a diagnosis of osteoarthritis and using MoM bearing surfaces ≤ 32 mm in diameter, defined as small-head MoM. The study group included 4838 primary THA with ≤ 32-mm MoM bearing surfaces. There were 2506 (51.8%) male patients and the median age of patients undergoing THA with a small-head MoM bearing surface was 64 years (range, 20-92 years of age). The outcome measure was the cumulative percent revision defined as the time to first revision using Kaplan-Meier estimates of survivorship at 15 years; reasons for revision and type of revision were also examined. We specifically investigated whether there was an increased risk of revision for ARMD in this MoM group compared with all other bearing surfaces. We compared these results with large-head MoM THAs (femoral head size > 32 mm). The cumulative percent revision for small-head MoM designs at 15 years was 8.5% (95% confidence interval [CI], 7.3-9.9). The cumulative percent revision for large-head MoM at 14 years was 27.4% (95% CI, 24.8-30.2). Prostheses with a large-head MoM articulation have a higher rate of revision than small-head MoM bearing surfaces (hazard ratio after 6 years, 5.14; 95% CI, 4.1-6.5; p < 0.001). Over time, there was a gradual increase in the diagnosis of ARMD for small-head MoM and the cumulative incidence of revision for ARMD was 0.8% at 15 years. Despite survival that is substantially greater than that of large-head MoM THAs, there has been a marked decrease in the use of small-head MoM designs in our registry. Although the reasons for this are likely multifactorial, the increasing incidence of revisions for ARMD among small-head MoM THAs is concerning. Level III, therapeutic study.

Which factors influence the rate of failure following metal-on-metal hip arthroplasty revision surgery performed for adverse reactions to metal debris? an analysis from the National Joint Registry for England and Wales.

AimsTo determine the outcomes following revision surgery of metal-on-metal hip arthroplasties (MoMHA) performed for adverse reactions to metal debris (ARMD), and to identify factors predictive of re-revision.Patients and MethodsWe performed a retrospective observational study using National Joint Registry (NJR) data on 2535 MoMHAs undergoing revision surgery for ARMD between 2008 and 2014. The outcomes studied following revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using competing-risk regression modelling.ResultsIntra-operative complications occurred in 40 revisions (1.6%). The cumulative five-year patient survival rate was 95.9% (95% confidence intervals (CI) 92.3 to 97.8). Re-revision surgery was performed in 192 hips (7.6%). The cumulative five-year implant survival rate was 89.5% (95% CI 87.3 to 91.3). Predictors of re-revision were high body mass index at revision (subhazard ratio (SHR) 1.06 per kg/m2 increase, 95% CI 1.02 to 1.09), modular component only revisions (head and liner with or without taper adapter; SHR 2.01, 95% CI 1.19 to 3.38), ceramic-on-ceramic revision bearings (SHR 1.86, 95% CI 1.23 to 2.80), and acetabular bone grafting (SHR 2.10, 95% CI 1.43 to 3.07). These four factors remained predictive of re-revision when the missing data were imputed.ConclusionThe short-term risk of re-revision following MoMHA revision surgery performed for ARMD was comparable with that reported in the NJR following all-cause non-MoMHA revision surgery. However, the factors predictive of re-revision included those which could be modified by the surgeon, suggesting that rates of failure following ARMD revision may be reduced further.Cite this article: Bone Joint J 2017;99-B:1020–7.

Outcomes following revision surgery performed for adverse reactions to metal debris in non-metal-on-metal hip arthroplasty patients: Analysis of 185 revisions from the National Joint Registry for England and Wales.

ObjectivesFew studies have assessed outcomes following non-metal-on-metal hip arthroplasty (non-MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD). We assessed outcomes following non-MoMHA revision surgery performed for ARMD, and identified predictors of re-revision.MethodsWe performed a retrospective observational study using data from the National Joint Registry for England and Wales. All non-MoMHAs undergoing revision surgery for ARMD between 2008 and 2014 were included (185 hips in 185 patients). Outcome measures following ARMD revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using Cox regression.ResultsIntra-operative complications occurred in 6.0% (n = 11) of the 185 cases. The cumulative four-year patient survival rate was 98.2% (95% CI 92.9 to 99.5). Re-revision surgery was performed in 13.5% (n = 25) of hips at a mean time of 1.2 years (0.1 to 3.1 years) following ARMD revision. Infection (32%; n = 8), dislocation/subluxation (24%; n = 6), and aseptic loosening (24%; n = 6) were the most common re-revision indications. The cumulative four-year implant survival rate was 83.8% (95% CI 76.7 to 88.9). Multivariable analysis identified three predictors of re-revision: multiple revision indications (hazard ratio (HR) = 2.78; 95% CI 1.03 to 7.49; p = 0.043); selective component revisions (HR = 5.76; 95% CI 1.28 to 25.9; p = 0.022); and ceramic-on-polyethylene revision bearings (HR = 3.08; 95% CI 1.01 to 9.36; p = 0.047).ConclusionsNon-MoMHAs revised for ARMD have a high short-term risk of re-revision, with important predictors of future re-revision including selective component revision, multiple revision indications, and ceramic-on-polyethylene revision bearings. Our findings may help counsel patients about the risks of ARMD revision, and guide reconstructive decisions. Future studies attempting to validate the predictors identified should also assess the effects of implant design (metallurgy and modularity), given that this was an important study limitation potentially influencing the reported prognostic factors.Cite this article: G. S. Matharu, A. Judge, D. W. Murray, H. G. Pandit. Outcomes following revision surgery performed for adverse reactions to metal debris in non-metal-on-metal hip arthroplasty patients: Analysis of 185 revisions from the National Joint Registry for England and Wales. Bone Joint Res 2017;6:405–413. DOI: 10.1302/2046-3758.67.BJR-2017-0017.R2.

Predictors of time to revision and clinical outcomes following revision of metal-on-metal hip replacements for adverse reaction to metal debris.

We undertook a retrospective cohort study to determine clinical outcomes following the revision of metal-on-metal (MoM) hip replacements for adverse reaction to metal debris (ARMD), and to identify predictors of time to revision and outcomes following revision. Between 1998 and 2012 a total of 64 MoM hips (mean age at revision of 57.8 years; 46 (72%) female; 46 (72%) hip resurfacings and 18 (28%) total hip replacements) were revised for ARMD at one specialist centre. At a mean follow-up of 4.5 years (1.0 to 14.6) from revision for ARMD there were 13 hips (20.3%) with post-operative complications and eight (12.5%) requiring re-revision. The Kaplan-Meier five-year survival rate for ARMD revision was 87.9% (95% confidence interval 78.9 to 98.0; 19 hips at risk). Excluding re-revisions, the median absolute Oxford hip score (OHS) following ARMD revision using the percentage method (0% best outcome and 100% worst outcome) was 18.8% (interquartile range (IQR) 7.8% to 48.3%), which is equivalent to 39/48 (IQR 24.8/48 to 44.3/48) when using the modified OHS. Histopathological response did not affect time to revision for ARMD (p = 0.334) or the subsequent risk of re-revision (p = 0.879). Similarly, the presence or absence of a contralateral MoM hip bearing did not affect time to revision for ARMD (p = 0.066) or the subsequent risk of re-revision (p = 0.178). Patients revised to MoM bearings had higher rates of re-revision (five of 16 MoM hips re-revised; p = 0.046), but those not requiring re-revision had good functional results (median absolute OHS 14.6% or 41.0/48). Short-term morbidity following revision for ARMD was comparable with previous reports. Caution should be exercised when choosing bearing surfaces for ARMD revisions.